Biotech Co. Secures Majority UK Gov Funding for Phase 3 Trial

Awakn Life Sciences Corp. (AWKN:NEO; AWKNF:OTCQB) is a Canada-based biotechnology developing firm commercializing therapeutics to treat addiction with a focus on Alcohol Use Disorder (AUD). Its therapeutics focus on the brain circuits that drive addiction, targeting multiple receptors rather than the single receptor targeting of older therapies.

Awakn's development segment focuses on repurposing ketamine in combination with therapy and developing methylenedioxy-methamphetamine (MDMA)-also in combination with therapy to treat substance and behavioral addictions.

Concurrently, the company's delivery segment, which includes a chain of psychedelic medical clinics across Europe, is expanding its reach by providing its drugs and service models as white-label solutions to various treatment operators in the U.S. market.

The Catalyst: Phase 3 Trial at a Fraction of the Cost

Yesterday (April 18, 2023), Awakn announced that it signed a collaboration agreement with the University of Exeter (UoE), putting in place a framework for an upcoming Phase 3 trial, exploring the use of ketamine-assisted therapy to treat severe AUD — a condition currently afflicting over 70 million adults worldwide. 

The global substance abuse treatment market, which overlaps somewhat with the alt therapies market, is projected to surpass US$23.1 billion by 2031.

This agreement formalizes the design, budget, and Awakn's contribution to the cost of the trial, which will be a Phase 3, n=280, two-armed, randomized, placebo-controlled study delivered in the UK across ten National Health Service (NHS) sites.

Under the terms of the agreement, the corporation will contribute GBP£ 800,000 toward the costs of the trial. The National Institute for Health and Care Research (NIHR), the Medical Research Council (MRC), and the UoE will cover the balance of the costs.

Considering that a 2018 Nature Reviews: Drug Discovery report lists the median cost of a Phase 3 trial at US$21.4 million, Awakn will be enjoying an enormous discount.

Why This Sector? Wide Demand for Psychedelic Medical Solutions

Demand for the reassessment of alternative therapies like Ketamine and MDMA has been growing steadily, with InsightAce Analytic projecting a total market valuation of US$8.31 billion by 2028.

While there are many avenues to explore in this newly-relevant market space, few companies are anywhere near Phase 3 trials, and none have announced any — especially not any this widely bankrolled by public institutions.

The global substance abuse treatment market, which overlaps somewhat with the alt therapies market, is projected to surpass US$23.1 billion by 2031. With a promising therapy currently closing in full availability, Awakn is poised to secure a considerable fraction of this market.

Why This Company? First to Get This Far

Once underway, Awakn's Phase 3 trial will be the largest ketamine-assisted psychological therapy clinical trial to date and the only Phase 3 psychedelic clinical trial to receive government funding. If the trial results are positive (as the results from phases I and II have been), Awakn plans, in due course, to apply for marketing authorization for ketamine-assisted therapy to treat severe AUD in multiple markets.

Celia Morgan, Professor of Psychopharmacology at UoE and Awakn's Head of Ketamine-

Assisted Therapy will lead the trial based on the results of the Phase II a/b trial announced in January 2022, which resulted in participants experiencing, on average, 86% abstinence at six months post-treatment versus 2% pre-trial.

Why Now? The Phase 3 Trial Inflection Point

In most cases, the Phase 3 trial is the last major hurdle blocking a newly-developed therapy from wide availability. While some two in five therapies fail to complete these trials, for those that do, passing usually represents the final inflection point – the last chance for a prospective investor to "get in on the ground floor."

In February 2023, Awakn received an Innovation passport as part of the Innovative Licensing and Access Pathway (ILAP) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This passport aims to accelerate the time to market for research programs, much like the FDA's fast-track designation.

Technical analyst Clive Maund said, "Awakn is rated a Buy for this at the current favorable entry price."

ILAP recognition will provide Awakn with access to specialist advice from the MHRA and its partners, including the National Institute of Health and Care Excellence (NICE).

As Awakn CEO Anthony Tennyson explained, "We are delighted to formalize an even stronger working collaboration and agreement with the University of Exeter, particularly when this gives such a clear roadmap for our Phase 3."

"We have been working side by side for several years now, and they are a world-leading institute for research and a partner we are very happy to work with. We share the same vision of providing a new, more effective treatment for AUD available to the millions of people who are in such desperate need for it."

Analyst Clive Maund, who has been following the company, reported on March 12 that Awakn's stock price "hit bottom early in November and has since been marking out a base pattern. There was a strong breakout move on persistent heavy volume early last month, although due to its moving averages still being unfavorably aligned, it was unable to hold the gains and has since dropped back into the base pattern."

"However, that attempt to break out, which is classed as a 'preliminary breakout,' has bullish implications, and with its volume pattern and volume indicators remaining very favorable and the price and moving averages converging, a successful breakout into a bull market looks set to occur soon, and it is rated a Buy for this at the current favorable entry price."

Ownership and Share Structure

Awakn's management owns 21.22% of the company's 35,602,993 fully-diluted structure, which consists of 28,799,011 common shares, 4,722,064 warrants, 1,996,746 outstanding options, and 35,172 DSUs.

Co-founder and Head of Psychedelic Medicine Dr. Ben Sessa owns the most, at 7.74%, with 2.23 million shares. Co-founder and chair George Scorsis is next at 1.84%, with 0.53 million shares. Non-Executive Director Steve Page is at 0.24% with 0.07 million shares. Co-founder and CEO Anthony Tennyson is at 0.08%, with 0.02 million shares, and the other non-executive director, Professor John Papastergiou, is at 0.03%, with 0.01 million shares.

OrbiMed Advisors LLC files as an insider, with an 8.35% equity stake (2,403,550 regular shares) and 989,583 warrants at US$0.68, while other warrants are all US$1.20 and higher.

Disclosures:

1) Owen Ferguson wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. They members of their household own securities of the following companies mentioned in the article: None. They or members of their household are paid by the following companies mentioned in this article: None.

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